Sealed back pressure breathing device

ABSTRACT

A hand-held breathing device for use by patients having respiratory problems creates a sealed backpressure in the airways of the patient by creating resistance to exhalation. A peep valve is mounted inside a hollow body, and a pre-set compression spring is mounted between the valve and an adjustable cap or cam lever in the main body of the device. A pair of valve openings extend through the wall of the main body, one opening serving as an intake port for inhaling of air by the patient and the second port—for exhalation of carbon dioxide. An intake valve is mounted inside the body between a normally open end of the device and the exhalation valve. In one of the embodiments, the device is attached to a nebulizer to facilitate buildup of positive pressure and delivery of medication to the patients&#39; lungs.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of my application Ser. No. 10/302,384filed on Nov. 22, 2002, now U.S. Pat. No. 6,659,100, which is acontinuation of my application Ser. No. 09/699,226 filed on Oct. 26,2000 for “Sealed Back Pressure Breathing Device,” now U.S. Pat. No.6,510,846, which is a continuation-in-part of my joint application, Ser.No. 09/471,553, filed on Dec. 23, 1999, entitled “Sealed Back PressureAttachment Device for Nebulizer,” now U.S. Pat. No. 6,412,481, the fulldisclosures of which are incorporated by reference herein.

BACKGROUND OF INVENTION

The present invention relates to a device for assisting pulmonaryfunctions of a patient; it can be used alone for exercising musclesinvolved in breathing or in combination with a nebulizer for delivery ofmedication to the airways of a patient. More particularly, the presentinvention relates to a breathing device for generating positivebackpressure in the airways of the user so as to keep the airways openand restore normal breathing.

Nebulizers are some of the most widely used devices for assistingpatients with breathing problems; they help deliver medication duringasthma attacks, emphysema attacks and similar occasions. Nebulizers areconventionally used in emergency rooms, by patients, and medicalprofessionals when conventional method metered dose inhalers (MDIs) failto reverse a constriction in the airways. The nebulizers break down theliquid medicine into tiny droplets that resemble mist and then deliverthe medication into the lungs and airways of the patient.

Conventionally, nebulizers dispense airway dilators. For example, when apatient is brought into an emergency room, he has an unusually highconcentration of carbon dioxide in blood. The nebulizer helps deliverthe much-needed dilators to the lungs and help expel the gas from thelungs. The dilators contain a chemical that reacts with the receptors inthe bronchioles of the patient to open the airways. The medications mayinclude steroids, magnesium sulfate, and bronchodilators.

However, conventional nebulizers are relatively slow, it may require upto eight hours of treatment. When a patient arrives in an acutecondition that requires an immediate treatment, an ambu bag with a maskis often used. The mask seals the moth and nose of the patient; when thebag is squeezed positive pressure forces the medication into theairways. This procedure is not free from complications. Air may bediverted into the patient's stomach and cause gastric distention orvomiting, which in turn increases the risk of aspiration since thevomited medium may be inhaled and forced into the lungs.

Some patients cannot be helped with either nebulizers or ambu bags; theyrequire a ventilator, an artificial breathing machine that works with anendotracheal tube inserted into the trachea of the patient. The positivepressure is much greater than when nebulizer with an ambu bag are used.Often times, excessive air is forced into the patient's lungs. Thelonger a patient stays on a ventilator, the more difficult it may be towean the patient from ventilator. Prolonged use of the ventilator tendsto cause atrophy of inspiratory muscles, which may become irreversible.

This invention contemplates elimination of drawbacks associated with theprior art and provision of hand-held devices that can be equally used bythe patient and by a medical professional for exercising inspiratorymuscles and for delivery of medication with the help of a nebulizer.

SUMMARY OF THE INVENTION

It is, therefore, an object of the present invention to provide a sealedcalibrated back pressure device that would allow creation of positivepressure on the constricted airways of a patient suffering from asthma,emphysema or other respiratory diseases.

It is another object of the present invention to provide a sealed backpressure breathing attachment device for a nebulizer that can be presetto create the desired amount of pressure and deliver the medication forrestoring the patient's breathing.

It is a further object of the present invention to provide a breathingdevice that would help in exercising inspiratory muscles of a patient.

These and other objects of the present invention are achieved through aprovision of a hand-held lightweight device that has a means foradjusting the amount of positive pressure created in the airways of thepatient. The device has a hollow body with a peep valve mounted on abracket inside the hollow body. The hollow body is provided with twothrough openings: an intake port and an exhalation port. An intakevalve, which can be as simple as a rubber gasket, is mounted in thehollow body between the exhalation valve and an open end.

The open end may carry a mouthpiece or be suitably sized and shaped tobe connected, via a manifold, to a nebulizer. The opposite closed end ofthe hollow body carries a means for adjusting the positive pressure. Inone of the embodiments, the adjustment means is a cap that threadablyengages the hollow body; in the second embodiment—it is an adjustablecam lever. A compression spring is mounted between the exhalation valveand the adjustment means. The calibration may be set to a desiredpressure, preferably between 5 cm and 20 cm of water.

BRIEF DESCRIPTION OF THE DRAWINGS

Reference will now be made to the drawings, wherein like parts aredesignated by like numerals, and wherein FIG. 1 is a perspective view ofthe attachment device in accordance with the first embodiment of thepresent invention.

FIG. 2 is a longitudinal sectional view of the device shown in FIG. 1showing the adjustable cap threadably engaged with the main body.

FIG. 3 is a longitudinal sectional view of the device of the firstembodiment, with the adjustable cap being separated from the main body.

FIG. 4 is a perspective view of the second embodiment of the device inaccordance with the present invention mounted on a manifold thatconnects the device to a nebulizer.

FIG. 5 is a longitudinal sectional view showing the embodiment of FIG. 4with an adjustable cam lever.

FIG. 6 is a longitudinal sectional view of the second embodiment showingair movement on inspiration and expiration.

FIG. 7 is a detail view showing a support bracket on the expirationvalve.

FIG. 8 is a detail front view showing the intake open on the exhalationvalve.

FIG. 9 is a detail view showing an intake valve.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Turning now to the drawings in more detail, numeral 10 designates thedevice in accordance with the first embodiment of the present invention.The device 10 comprises an elongated main hollow body 12 having a firstcylindrical portion 14, a unitary connected middle conical portion 16,and a mouthpiece 18, which is unitary connected to the middle portion16. A central opening 20 is formed in the body 12, extending from themouthpiece opening 22, through the mouthpiece 18, conical portion 16,and the main body 14.

An adjustable screw cap 24 closes the normally closed end 26 of the mainbody portion 14. The cap 24 is provided with threads 28 on the innerwall of the cap. The threads 28 matingly engage with threads 30 on theexterior wall of the end 26. A central plug 32 is formed in the cap 24,the plug 32 extending outwardly from an inner end 34 of the cap 24. Theend 34, as can be better seen in FIG. 3, forms an annular shoulder thatprovides a first abutting surface, against which a compression spring 40abuts, as will be described in more detail below.

An intake port 42 is cut through the wall of the hollow body 12, and anexhalation port 44 is formed in the main body portion 14, at a locationspaced apart from the intake port 42. Positioned between the ports 42and 44 is an exhalation peep valve 50, which is shown in an open intakeposition in more detail in FIG. 7. The valve 50 is the same valve thatis used in the first and second embodiments of the present invention;therefore, its description will be omitted when the second embodiment isdescribed hereinafter.

The exhalation valve 50 is mounted on a support bracket, or frame 52that is fitted inside the main body portion 14. The support bracket 52is provided with an annular flange 54 that frictionally engages theinner wall of the main portion 14. The inner corner of the flange 54provides a second abutting surface for the compression spring 40.

An inwardly extending shoulder 56 is formed on the inner wall of themain portion 14 adjacent to the area of connection between the mainportion 14 and the conical portion 16. The shoulder forms a stop whenthe bracket 52, along with the peep valve 50 is forced against theshoulder 56.

An intake valve 60 (FIG. 9) is mounted in the main portion 14 between anopen end 22 and the bracket 52. The intake valve 60 can be as simple asa flexible rubber gasket that forms a one-way valve that opens duringinhalation. The diameter of the circular intake valve 60 is smaller thanthe inner diameter of the opening 20 in the main portion 14, allowingsome air to move around the intake valve 60. The intake valve, or flap60 is made from a flexible material, for example latex. The flap laysover the ports of the piston/bracket 52 when pressure is against thepiston and against the spring 40, but flaps open through the openings inthe bracket allowing intake of fresh air.

When the device 10 is assembled, the spring 40 abuts, at one of itsends, against the inner end, or shoulder 34, around the plug 32. Thesecond end of the spring 40 abuts against the valve 50 mounted in thebracket 52, normally forcing the peep valve in a closed position shownin FIG. 2. The valve opens on intake of air, as shown in FIG. 8, butoffers the pre-set resistance to a gas flow during exhalation.

When the user needs to exercise the muscles or simply distend airways,he closes his lips around the open end 22 of the mouthpiece 18. Duringinhalation, the air travels from the intake port 42, through the valve50, around the valve 60, and into the open end 22 of the mouthpiece 18.On exhalation, the flow of gas is reversed, moving from the open end 22,around the valve 60, and against the resistance of the compressionspring 40, into the directional exhalation port 44. In order forexhalation gas to exit the body 12, the user must exert sufficientpressure on the spring 40 to move the bracket 52 into a position awayfrom the exit port 44 to allow the gas to be expelled.

Since the spring 40 offers resistance to the opening of the peep valve50, a positive back pressure is created in the airways of the patient,forcing the patient to apply more force in exhaling, therebystrengthening the muscles involved in breathing. The cap 24, being incontact with the spring 40 can be screwed more or less tightly on thebody 12, allowing adjustment for creation of positive pressure in therange of 5 cm to 20 cm of water. This range was found sufficient formost of the patients, although other pressure adjustments may be easilymade if desired.

Turning now to the second embodiment shown in FIGS. 4-6, the nebulizerattachment device 70 is illustrated. The device 70 comprises anelongated, generally cylindrical body 72 that has a normally open end 74and a normally closed end 76. An adjustable cam lever 78 is secured to ashaft connected to a piston 94 mounted in the end 76 to allow adjustmentof the pressure required for opening and closing of the peep valvemounted inside the body 72. The pressure may be adjusted to a desiredvalue, for example in the range of 5 cm to 10 cm of water, depending onthe user's condition.

The adjustment may be accomplished by regulating position of the lever.For example, a first position would indicate pressure of 5 cm of water.By flipping the lever in an opposite direction, the user may regulatecompression of the spring to create pressure of about 10 cm of water. Ofcourse, the movement of the cam lever 78 may be calibrated to anypressure in between the desired range, setting different positions onthe body 72 and indicating the setting by suitable indicia.

The body 72 is provided with a directional intake port 80 and adirectional exhalation port 82. The open end 74 is adapted forfrictional engagement with a manifold 84 that carries a mouthpiece 86and a conventional nebulizer 88. The manifold 84, mouthpiece 86, andnebulizer 88 are not part of this invention; they are shown in phantomlines in FIG. 4.

Referring now to FIGS. 5 and 6, the interior of the device 70 is shownin more detail. As can be seen in FIG. 5, the body 72 is provided with acentral opening 90 that extends from the open end 74 to the closing wall92 of the closed end 76. The cam lever 78 is rotatably mounted on ashaft 77 (FIG. 6) that is fixedly attached to the wall 92 of the closedend 76. The piston 94 moves a small distance within the central opening90 only to adjust compression of a spring 96.

The compression spring 96 is mounted between the piston member 94 andthe exhalation valve peep valve 98. The valve 98 is similar is allrespects to the valve 50 and, therefore its detail description isomitted here. The exhalation peep valve 98 allows creation of positiveback pressure by forcing the patient to exhale against the force of thecompressed spring 96. An intake valve, similar to the valve 60 is in thebody 72 between the open end 74 and the valve 98.

During intake of air, the air travels through the port 80, through thevalve 98 and intake valve 60 in the direction of arrow 100. Duringexhalation, or expiration, the air moves against the rubber gasket, orflap valve 60 that normally closes the ports of the piston/bracket. Bycontinuing exhalation, the patient is able to move the bracket, againstresistance of the compression spring 96, away from the exhalation port82, allowing the gas to move through the exhalation peep valve 98 andthrough the exhalation port 82, in the direction of arrow 102, as shownin FIG. 6.

Once the adjustable cam lever 78 is set for the desired resistance toair movement, the device 70 is mounted on the manifold 84 and becomesconnected to the nebulizer 88. A quantity of medication 104 deposited inthe nebulizer 88 mixes with the air passing through the manifold 84 tothe mouthpiece 86 and is delivered to the airways of the patient. Thetiny droplets of medication dispersed by the aerosol-forming member 106intercept the airflow passing through the body 72. The formed mist mixeswith the intake airflow and is delivered into the airways of the user,extending the airways and reducing the asthma attack or other breathingproblems of the patient.

It is preferred that during exhalation or inhalation, the patients keeptheir mouths firmly closed around mouthpieces 18 and 86, so as to sealthe open ends of the devices 10 and 70 and to allow effective deliveryof medication and exhalation of gases. When the patient exhales, thepeep valve tends to distend airways of the patient and preventcollapsing of the alveoli by creating a positive back pressure.

When the air is forced to exit only through the exhalation valve thathas been pre-set to offer resistance by a cap 24 or by the cam 78, theexhaust airflow cannot exit through the intake port and has to movethrough the exhalation ports 44 or 82. By keeping a sealed positivebackpressure in the devices 10 and 70, the airways of the patients arekept open restoring the normal breathing. Once the pressure inside theinflamed sac is equalized with the pressure in a trachea, the medicationhas a much better chance to penetrating deep into the airways and causedilation.

The devices 10 and 70 allow trapped carbon dioxide to escape through theexhalation ports 44 or 82, thereby reducing the toxic levels of carbondioxide into the blood stream of the user. When the trapped gases areremoved from the lungs, the lungs can then generate a greaterinspiratory pressure with less effort of the patient.

Once the airways are extended, the pyramid effect establishes itselfthus increasing the flow of much needed oxygenated air. The user,allowing pressure equalization and increase of volume in all lung areas,experiences a long expiratory phase. Once the airways are extended, theair movement into and out of the lungs is considerably improved. Thelungs are not hyper-inflated; fresh air enters the lungs with more ease.

Additionally, if the attachment 70 is used, the medicine 104 is pulledin from the nebulizer 88 more effectively to reach the affected areas ofthe lungs and further dilate the airways. Consequently, the patient'scollapsed or obstructed airways remain open and more precise medicationdelivery may be achieved. The treatment then becomes more effective withless medication.

The present invention can be used for patients suffering from asthma oremphysema. Many patients suffering from asthma have unexpected attacksand difficulty of getting to their medication. The attack may beenhanced by anxiety that the patient would suffocate before getting themedication. By having a small portable device readily available, thepatient can at least restore some breathing and reduce the anxietyfactor.

During an emphysema attack, the terminal bronchioles are weakened andare in a permanently enlarged condition. The alveolar walls are oftentimes damaged. Because of the loss of alveolar space, the amount ofsurface area for gas exchange is reduced, and the elastic recoil of thelung tissue is diminished.

It is the lack of elasticity that causes inadequate lung recoil andfatigues inspiratory muscles. The lungs are unable to properly relax andreturn to their normal position. Under such conditions, patients areoften advised to breathe with “pursed lips.” By using, the sealed backpressure devices 10 or 70, that emphysema sufferers can increasedelivery of air into the lungs and exhaust the carbon dioxide from theblood stream.

The backpressure created by the devices 10 and 70 prevents thebronchioles, alveoli from collapsing. The reduction of resultanthyperinflation allows the patient to inspire and exhale more fully,thereby delivering medication to a greater surface of the damagedtissue. Additionally, the sealed back pressure helps to keep the alveoliand airways open, allowing the release of the carbon dioxide from thelungs into the atmosphere. The effective removal of gas from the lungsand the blood stream improves the physiological function of the patientand allows more oxygen to be delivered into the lungs.

It is envisioned that the valve 10 and 70 can be preset to greatervalues than indicated above, particularly with patients havingconsiderable problems with collapsed airways, although the preferredsettings would range from about 5 cm to 20 cm of water.

It is envisioned that the devices of the present invention may be usedfor exercising the patients and restoring their ability to normallybreathe. This is particularly true with a device 10 of the firstembodiment. It is also envisioned that a nose clip and/or a moldedcushioned mouthpiece may be used in combination with the mouthpieces toensure a better seal of the patients' lips around the mouthpiece.

The device of the present invention can be inexpensively manufacturedfrom readily available materials, such as plastic and lightweight metal.The springs 40 and 96 will naturally be manufactured from a materialthat is strong enough to withstand multiple compressions and expansionsduring use of the device. It is envisioned that the mouthpiece 18 may bemanufactured to detachably engage the main body portion 14, if desired.In such a case, the device 10 with separated mouthpiece 18 may becarried in a compact space, such as the user's pocket, and engaged withthe rest of the device, when needed.

The device 70 may be attached to a metered dose inhaler (MDI), insteadof a nebulizer, if necessary. In such a case, a mini spacer would beused instead of the manifold 84. The mini spacer conventionally has aport for delivery of medication, for example anti-inflammatory drugs, inthe form of a fine mist.

Many changes and modifications may be made in the design of the presentinvention without departing from the spirit thereof. I, therefore, praythat my rights to the present invention be limited only by the scope ofthe appended claims.

I claim:
 1. A sealed back pressure device for assisting a respiratoryfunction of a patient, comprising: an elongated hollow body having afirst normally open end, a second normally closed end, an intake portand an exhalation port; a one-way exhalation valve mounted inside thehollow body for allowing exhaust gas to be exhaled through theexhalation port; an intake valve mounted between said open end and saidexhalation valve; a compression spring mounted between the exhalationvalve and the closed end for regulating resistance to gas flow beingexhaled by the patient; and a means mounted on the second end of thehollow body for adjusting compression of the spring.
 2. The device ofclaim 1, wherein said intake valve comprises a rubber gasket.
 3. Thedevice of claim 2, wherein an adjustable cam lever is mounted on saidpiston for adjusting resistance to an exhalation gas flow.
 4. A sealedback pressure device for assisting a respiratory function of a patient,comprising: an elongated hollow body having a first normally open end, asecond normally closed end, an intake port and an exhalation port; aone-way exhalation valve mounted inside the hollow body for allowingexhaust gas to be exhaled through the exhalation port; a compressionspring mounted between the exhalation valve and the closed end forregulating resistance to gas flow being exhaled by the patient; and ameans mounted on the second end of the hollow body for adjustingcompression of the spring, and wherein said adjusting means comprises asliding piston movable inside said hollow body, said piston providing anabutment surface for said compression spring.
 5. The device of claim 4,wherein said cam lever is adjustable to maintain a positive backpressure in the range of between 5 and 10 centimeters of water.
 6. Asealed back pressure device for assisting respiratory functions of apatient, comprising: an elongated hollow body having a first normallyopen end, a second normally closed end, an intake port formed through awall of the hollow body and an exhalation port formed through the wallof the hollow body a distance from said intake port for communicatinginterior of the hollow body with the atmosphere; a one-way exhalationvalve carried by a supporting bracket and mounted inside the hollow bodyfor allowing exhaust gas to be exhaled through the exhalation port; anintake valve mounted between said open end and said exhalation valve; acompression spring mounted between the exhalation valve and the closedend for maintaining a positive back pressure and regulating resistanceto gas flow being exhaled by the patient; and a means mounted on thesecond end of the hollow body for adjusting compression of the spring,said adjusting means comprising a cap detachably mounted on the secondend, said cap providing a first abutting surface for said compressionspring, said support bracket providing a second abutting surface forsaid compression spring, and wherein said open end is provided with amouthpiece for engagement by lips of the patient.
 7. A sealed backpressure device for assisting respiratory functions of a patient,comprising: an elongated hollow body having a first normally open end, asecond normally closed end, an intake port formed through a wall of saidhollow body and an exhalation port formed through the wall of saidhollow body a distance from said intake port for communicating interiorof said hollow body with the atmosphere; a one-way exhalation valvecarried by a supporting bracket and mounted inside the hollow body forallowing exhaust gas to be exhaled through the exhalation port; acompression spring mounted between the exhalation valve and the closedend for maintaining a positive back pressure and regulating resistanceto gas flow being exhaled by the patient; a means mounted on the secondend of the hollow body for adjusting compression of the spring, saidadjusting means comprising a sliding piston movable inside said hollowbody, said piston providing a first abutment surface for saidcompression spring and said support bracket providing a second abuttingsurface for said compression spring, and wherein said hollow body isadapted for attachment to a nebulizer for establishing fluidcommunication between said hollow body and the nebulizer for delivery ofmedication to airways of the patient.
 8. The device of claim 7, whereinan adjustable cam lever is mounted on said piston for adjustingresistance to an exhalation gas flow.
 9. The device of claim 8, whereinsaid cam lever is adjustable to maintain a positive back pressure in therange of between 5 and 10 centimeters of water.
 10. The device of claim7, wherein said open end of the hollow body is detachably securable tothe nebulizer.